FDA 510(k)

SIGNA 7.0T

K-Number: K201615 · 2020-10-15

Decision Date2020-10-15

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SIGNA 7.0T is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2020-10-15 under approval number K201615. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNA 7.0T?

SIGNA 7.0T is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K201615.

When was SIGNA 7.0T approved by the FDA?

SIGNA 7.0T received FDA 510(k) clearance on 2020-10-15, under approval number K201615.

What company makes SIGNA 7.0T?

SIGNA 7.0T is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for SIGNA 7.0T?

The FDA product code for SIGNA 7.0T is LNH.

Other Devices by Ge Medical Systems, LLC

K163213Revolution CT K162403HyperBand K162990Optima XR240amx K161397MAGiC K161574Discovery MI K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T

View all 42 devices →

Related Devices (Code: LNH)

K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc. K162403HyperBandGe Medical Systems, LLC K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc. K161973G-scan Brio, S-scanEsaote, S.p.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.